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Exploratory Open-Label, Non-randomised, Single Centre Methodology Study Comparing DCE-CT and DCE-MRI as Markers of Changes in Vascular Activity Mediated by a Positive Control Agent [Cediranib (Recentin™; AZD2171), a Potent Inhibitor of VEGF-driven Angiogenesis] in Patients With Advanced Solid Tumour


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Exploratory Open-Label, Non-randomised, Single Centre Methodology Study Comparing DCE-CT and DCE-MRI as Markers of Changes in Vascular Activity Mediated by a Positive Control Agent [Cediranib (Recentin™; AZD2171), a Potent Inhibitor of VEGF-driven Angiogenesis] in Patients With Advanced Solid Tumour


Inclusion Criteria:



- Histologically confirmed metastatic tumour which is refractory to standard therapies

- At least one lesion size ≥3cm on in longest diameter suitable for repeat assessment
by DCE-CT and DCE-MRI

- Patients must be able to undergo DCE-CT and DCE-MRI scanning procedures

- Life expectancy of at least 12 weeks

Exclusion Criteria:

- Patients with hormone refractory prostate cancer (HRPC)

- Patients with a history of poorly controlled high blood pressure

- Ineligibility for MRI scanning or DCE-CT or DCE-MRI scanning

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities.

Outcome Time Frame:

DCE-MRI and DCE-CT scans taken at Baseline, Day 7 and Day 28. Comparison between modalities from scans taken on Days -8 and Day-1.

Safety Issue:

No

Principal Investigator

Jane Robertson, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca, Alderley Park

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D1330C00003

NCT ID:

NCT00748891

Start Date:

August 2008

Completion Date:

November 2010

Related Keywords:

  • Cancer
  • Cancer
  • tumour
  • advanced sold tumour
  • imaging
  • DCE-CT Scan
  • DCE-MRI scan
  • Cediranib
  • Recentin

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